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临床试验/NCT02655484
NCT02655484已完成不适用

Evaluation of Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
mean exhalation valve flow

研究概览

简要总结

The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects or patients with COPD ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for predicting CO2 rebreathing.

详细描述

Non-invasive ventilation circuit consists of single-limb tubing for inspiration and expiration, including a plateau exhalation valve. As exhaled gases was vented out the plateau exhalation valve at a constant rate, during exercise, with the increase of exhalation flow, single-limb circuit with a plateau exhalation valve might cause carbon dioxide(CO2) rebreathing. Therefore, our aim in the present study was to evaluate whether CO2 rebreathing occurs in COPD patients ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve and estimate a potential threshold for predicting CO2 rebreathing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • presented clinically stable (no exacerbation in the 4 weeks prior to study participation or with no change in medications);
  • physician diagnosed COPD, forced expiratory volume in 1s (FEV1) < 50% predicted;
  • dyspnea as a main symptom that limited daily activities.

排除标准

  • subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray;
  • examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy;
  • a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations;
  • a history of uncontrolled hypertension, or other respiratory diseases;
  • oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen (FiO2) ≥ 0.5;
  • patients with musculoskeletal or neurological disorders;
  • or failure to comply with the research protocol.

结局指标

主要结局

mean exhalation valve flow

时间窗: Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.

次要结局

  • mean inspiratory fraction of CO2 for each tidal volume(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)
  • fraction of end-tidal carbon dioxide partial pressure(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)
  • inspiratory time(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)
  • expiratory time(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)
  • respiratory rate(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)
  • mean exhalation flow(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)
  • inspiratory tidal volume(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)
  • expiratory tidal volume(Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process.)

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

RongChang Chen

director of Guangzhou Institute of Respiratory Disease

Guangzhou Institute of Respiratory Disease

研究点 (1)

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